Clinical benefit and regulatory outcomes of cancer drugs receiving accelerated approval

JAMA

7 May 2024 - In this cohort study of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did not improve overall survival or quality of life in confirmatory trials after more than 5 years of follow-up, with results not yet available for another 15% (7/46). 

Among drugs converted to regular approval, 60% (29/48) of conversions relied on surrogate measures.

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Michael Wonder

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Michael Wonder